The present invention is related to a blood analysis method and apparatus utilizing a standard microscopic optical system to analyze whole blood subsequent to the administration of a biological product. The invention is concerned with the analysis of blood for proper physical or chemical response to vaccines and other biological products as described below.
The device can be used to analyze the chemical or physical reaction of blood by measuring the electrolytes, antibody levels and cell count in a capillary chamber having a plurality of capillary tubes. Several physical or chemical exams can be conducted using the sample from an initial puncture of the patient or from collected blood samples. The aim is to produce a plurality of aliquots of blood for the on-site hematological examination of the blood.
The administration of any biological product, including vaccines, can create side effects. Some reactions to biological products might be subtle and the patient would eventually recover. For example, a patient might experience redness, warmth, or swelling in the location where the shot was administered (see Table 1 below). It is also known that patients can faint after the administration of a vaccine. Some patients experience severe pain in the shoulder and might have difficulty moving the arm. Most of these side effects are mild and would eventually subside after a few days.
TABLE 1VACCINESIDE EFFECTSAdenovirusheadaches, fever and abdominal painAnthraxheadaches, fatigue, lump and tendernessDTaP (Diphtheria, Tetanusfussiness, tiredness, vomiting, seizure,and Cellular Pertussis)fever, coma and brain damageHepatitis Asoreness, fatigue, loss of appetite andheadacheHepatitis Bsoreness where the shot was givenand temperature of 99.9° F. or higherHib (Haemophilus influenzaeredness, warmth, or swelling where thetype b)shot was given and feverHPV-Cervarixheadache, pain, jerking spells and faintingHPV--Gardasil-9fever, headache, redness and swellingInactivated Influenzarisk of Guillain-Barré Syndrome (GBS),seizure and fainting
A vaccine, like any medicine, can cause a serious reaction. For example, in the case of the DTaP (Diphtheria, Tetanus and Cellular Pertussis) vaccine shown above, serious allergic reaction can occur in less than 1 out of a million cases. These severe reactions include long-term seizures, coma, lowered consciousness or permanent brain damage. Additional reactions to DTaP have been reported. Moderate reported problems include seizure, jerking or staring (about 1 child out of 14,000), non-stop crying for 3 hours or more (up to about 1 child out of 1,000) high fever, 105 degrees Fahrenheit or higher (about 1 child out of 16,000).
An increased number of scientists have questioned the use of preservatives in vaccines. These are compounds that minimize the growth of microorganisms in a vaccine. In the case of multi-dose vials that are repeatedly used in a clinical setting, a preservative would prevent microbial growth. In most cases, manufacturers add the preservatives in the production stage of the vaccine.
Thimerosal is a mercury-containing preservative that has been widely used in vaccines. Some scientists believe that this preservative can cause autism and other neurodevelopmental disorders. The scientific community agrees that the risk of a vaccine causing serious harm, or death is extremely small and in most cases, severe allergic reactions are believed to occur about once in 1.1 million doses. However, hundreds of millions of people have been vaccinated and it is likely that parental and patient concern would increase with the knowledge that there is a risk of any complication.
In the event of patient or parental concern regarding the side effects or administration of biological products, the invention as described herein can be employed. The improved blood analysis method and apparatus of the present invention would reduce the number of personnel and the amount of equipment needed to perform physical and chemical analysis of blood. The core blood tests would be analyzed and stored in a single location. For example, the complete metabolic profile of a blood sample measuring electrolytes, protein level and liver enzymes could be produced using one or more of the plurality of capillary tubes. A separate capillary tube can be used to measure a complete blood count of a patient including the automatic differential of the white blood cells, neutrophils, lymphocytes, monocytes basophils and eosinophils.
Mandatory rules under the Occupational Safety and Health Agency (OSHA) guidelines must be strictly applied to all collection of blood or other testing samples. The venipuncture site should be cleansed before and after puncture and completed using standard venipuncture techniques. It can be cleaned with required antiseptic such as betadine or 70% isopropyl alcohol.
The administration or handling of this system is to be performed by a trained medical practitioner or scientist. This analysis system would require proficient administration and particular attention to hygiene concerns before and after use of the product. The scientist or medical practitioner must pay keen attention to the appropriate method for the collection and storage of blood for analysis using the described capillary chamber.
This system is also suitable for mass production. It features a simple design and construction that provides for easy handling and appropriate disposal after blood collection and analysis.